Health Care Technology Official British Standard

ASTM F136 - 13(2021)e1

Discover ASTM F136 - 13(2021)e1, a vital standard for titanium alloy materials used in surgical implants, ensuring safety and compliance in healthcare technology.

ASTM F136 - 13(2021)e1: Comprehensive Overview

ASTM F136 - 13(2021)e1 is an essential standard specifically developed for biomedical manufacturers, healthcare professionals, and regulatory agencies. This standard defines the requirements for titanium and titanium alloy materials intended for surgical implants. Since its initial publication, this standard has been instrumental in ensuring the quality, safety, and efficacy of medical devices used in patient care.

One of the critical aspects outlined in ASTM F136 is the classification of titanium alloys based on their mechanical properties, biocompatibility, and corrosion resistance. The standard provides a framework for assessing the performance of these materials in the physiological environment, ensuring that they can withstand the demands of various surgical applications.

The document is divided into several sections, each of which covers different facets important to the evaluation of titanium alloys. The specifications include detailed descriptions of chemical composition, mechanical properties, microstructure, and testing methods. This breadth of information equips manufacturers with a thorough understanding of the properties required for compliance with industry standards.

Furthermore, the standard emphasizes the importance of rigorous testing protocols to validate the material's performance. By adhering to these validated methods, manufacturers can provide empirical data that supports the safe use of their products in medical applications. The ASTM F136 standard is updated regularly to reflect current research findings and technological advancements in the field, ensuring that all stakeholders have access to the latest guidelines and best practices.

In addition, ASTM F136 is complemented by other related standards, enhancing its utility in the healthcare technology domain. It serves as a cornerstone for quality assurance processes and regulatory compliance in the implantable devices market, encompassing orthopedic, dental, and cardiovascular applications.

This product is available in both PDF and hard copy formats, making it easily accessible for those in the healthcare technology sector. For a price of £68.00, stakeholders can obtain a reliable resource that aids in the development of safe and effective medical devices, thereby safeguarding patient outcomes and advancing the standards of care.

In conclusion, ASTM F136 - 13(2021)e1 is not just a standard; it is a critical tool in the healthcare industry, aiding in the design, testing, and implementation of titanium alloys for surgical implants.

Technical Information

Health Care Technology
BSI Group
Specification Details
  • Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
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